A Study of Oral Venetoclax Tablets and Oral Azacitidine a... | NCT04102020 | Trialant
NCT04102020
Sponsor
AbbVie
Status
Completed
Last Update Posted
Apr 8, 2026Actual
Enrollment
112Actual
Phase
Phase 3
Conditions
Acute Myeloid Leukemia (AML)
Interventions
Venetoclax
Azacitidine
Azacitidine
Countries
United States
Australia
Canada
China
Czechia
France
Germany
Greece
Hungary
Israel
Italy
Japan
Puerto Rico
Russia
South Korea
Spain
Taiwan
Turkey (Türkiye)
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT04102020
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
M19-708
Secondary IDs
ID
Type
Description
Link
2023-507221-42-00
Other Identifier
EU CT
Brief Title
A Study of Oral Venetoclax Tablets and Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
Official Title
Multicenter, Phase 3 Study of Venetoclax and Azacitidine as Maintenance Therapy for Patients With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy
Acronym
VIALE-M
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
Aug 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
YesNCT03123029Available
Start Date
Mar 26, 2020Actual
Primary Completion Date
Sep 29, 2022Actual
Completion Date
Feb 20, 2026Actual
First Submitted Date
Sep 23, 2019
First Submission Date that Met QC Criteria
Sep 23, 2019
First Posted Date
Sep 25, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Jul 29, 2025
Results First Submitted that Met QC Criteria
Aug 19, 2025
Results First Posted Date
Aug 20, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Aug 29, 2023
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Aug 20, 2025Actual
Last Update Submitted Date
Mar 20, 2026
Last Update Posted Date
Apr 8, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbVieINDUSTRY
Collaborators
Name
Class
Roche-Genentech
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose (RPTD) of venetoclax in combination with azacitidine (AZA). Part 3 will be the Dose Finding portion to determine RPTD of venetoclax in combination with AZA. Part 2 and Part 3 Randomization of the study were removed.
Detailed Description
Not provided
Conditions Module
Conditions
Acute Myeloid Leukemia (AML)
Keywords
Acute myeloid leukemia (AML)
Venetoclax
Azacitidine (AZA)
Maintenance Therapy
Conventional Chemotherapy
Best supportive care (BSC)
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
112Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1: Dose Confirmation
Experimental
Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 24 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles.
Drug: Venetoclax
Drug: Azacitidine
Part 3 (Dose Finding): Dose Escalation
Experimental
Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles to determine recommended phase 3 dose (RPTD).
Drug: Venetoclax
Drug: Azacitidine
Part 3 (Dose Finding): Safety Expansion
Experimental
Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles at the RPTD.
Drug: Venetoclax
Drug: Azacitidine
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Venetoclax
Drug
Tablet: Oral
Part 1: Dose Confirmation
Part 3 (Dose Finding): Dose Escalation
Part 3 (Dose Finding): Safety Expansion
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Dose-Limiting Toxicities (DLTs) of Venetoclax in Combination With Azacitidine (AZA) (Part 1)
DLTs are any of the hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax as described in the protocol and evaluated by the Investigator and the sponsor.
Up to 28 days (Cycle 1)
Number of Participants With DLTs of Venetoclax in Combination With Oral AZA (Part 3 Dose Finding Portion)
DLTs are hematologic toxicities consisting of any Grade ≥ 3 neutropenia or thrombocytopenia lasting more than 7 days and nonhematologic toxicities as described in the protocol and evaluated by the Investigator and the Sponsor. In addition, AEs that lead to omitting > 20% of the scheduled dose within the cycle is considered as a DLT unless clearly related to underlying disease. Treatment delay due to toxicity lasting greater than 14 days since the last dose of Venetoclax is also considered a DLT.
Up to 28 days (Cycle 1)
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosis of newly diagnosed acute myeloid leukemia (AML).
Participant meets the following disease activity criteria:
Confirmation of AML by World Health Organization (WHO) criteria (2016) and have confirmed complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following completion of intensive induction and consolidation chemotherapies.
Achieved first CR + CRi within 120 days of first dose of study drug or be no more than 75 days since last dose of intensive conventional (including both induction and consolidation) chemotherapies.
AML has intermediate or poor risk cytogenetics per National Comprehensive Cancer Network (NCCN) 2016 criteria.
Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.
Exclusion Criteria:
History of acute promyelocytic leukemia (APL).
History of active central nervous system involvement with acute myeloid leukemia (AML).
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
ABBVIE INC.
AbbVie
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Mitchell Cancer Institute /ID# 216443
Mobile
Alabama
36604
United States
Compassionate Cancer Care Research Group - Fountain Valley /ID# 216156
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 24 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles.
Venetoclax: Tablet: Oral
Azacitidine: Subcutaneous (SC) or intravenous (IV) injection
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Apr 26, 2024
Jul 29, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Austria
Brazil
Poland
Portugal
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
ABT-199
GDC-0199
Venclexta
Azacitidine
Drug
Subcutaneous (SC) or intravenous (IV) injection
Part 1: Dose Confirmation
Azacitidine
Drug
Oral Tablet
Part 3 (Dose Finding): Dose Escalation
Part 3 (Dose Finding): Safety Expansion
Fountain Valley
California
92708-7501
United States
University of California, Los Angeles /ID# 219149
Los Angeles
California
90095
United States
Colorado Blood Cancer Institute /ID# 214280
Denver
Colorado
80218
United States
St. Alphonsus Regional Medical /ID# 216424
Boise
Idaho
83706
United States
Duplicate_Rush University Medical Center /ID# 218815
Chicago
Illinois
60612
United States
University of Kentucky Markey Cancer Center /ID# 215048
Hospital Universitario Virgen de la Victoria /ID# 214713
Málaga
29010
Spain
National Taiwan University Hospital /ID# 213939
Taipei City
Taipei
100
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 213953
Kaohsiung City
807
Taiwan
China Medical University Hospital /ID# 213952
Taichung
40447
Taiwan
Linkou Chang Gung Memorial Hospital /ID# 213951
Taoyuan City
333
Taiwan
Gulhane Askeri Tip Academy /ID# 214242
Ankara
06010
Turkey (Türkiye)
Ankara Univ Medical Faculty /ID# 214239
Ankara
06590
Turkey (Türkiye)
Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi /ID# 215525
Istanbul
34098
Turkey (Türkiye)
Erciyes University Medical Faculty /ID# 214240
Kayseri
38039
Turkey (Türkiye)
Karadeniz University /ID# 214241
Trabzon
61000
Turkey (Türkiye)
Leicester Royal Infirmary /ID# 215924
Leicester
England
LE1 5WW
United Kingdom
Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 215909
London
Greater London
E1 2ES
United Kingdom
Duplicate_UCLH NHS Foundation Trust - University College Hospital /ID# 215921
London
Greater London
NW1 2PG
United Kingdom
Dup_Guys and St Thomas NHS Foundation Trust - Guy's Hospital /ID# 215908
London
Greater London
SE1 9RT
United Kingdom
Cardiff & Vale University Health Board /ID# 215906
Cardiff
Wales
CF14 4XN
United Kingdom
University Hospitals Birmingham NHS Foundation Trust /ID# 215910
Birmingham
B15 2TH
United Kingdom
University Hospitals Bristol /ID# 215911
Bristol
BS1 3NU
United Kingdom
Shallis RM, Podoltsev NA. Maintenance therapy for acute myeloid leukemia: sustaining the pursuit for sustained remission. Curr Opin Hematol. 2021 Mar 1;28(2):110-121. doi: 10.1097/MOH.0000000000000637.
Part 1: Venetoclax 400 mg + Azacitidine 36 mg/m^2
Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 24 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles.
Venetoclax: Tablet: Oral
Azacitidine: Subcutaneous (SC) or intravenous (IV) injection
FG002
Part 1: Venetoclax 400 mg + Azacitidine 50 mg/m^2
Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 24 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles.
Venetoclax: Tablet: Oral
Azacitidine: Subcutaneous (SC) or intravenous (IV) injection
Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles to determine recommended phase 3 dose (RPTD).
Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles at the RPTD.
Venetoclax: Tablet: Oral
Azacitidine: Oral Tablet
FG00023 subjects
FG00123 subjects
FG00220 subjects
FG00330 subjects
FG00416 subjects
COMPLETED
Data included are subject to a cutoff date of 05OCT2022.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
NOT COMPLETED
FG00023 subjects
FG00123 subjects
FG00220 subjects
FG00330 subjects
FG00416 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG004
Death
FG0001 subjects
FG0014 subjects
FG0021 subjects
FG0031 subjects
FG004
Physician Decision
FG0001 subjects
FG0012 subjects
FG0022 subjects
FG0030 subjects
FG004
COVID-19 Infection
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Not disclosed
FG0005 subjects
FG0013 subjects
FG0028 subjects
FG0030 subjects
FG004
MIssing
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Continuing in ongoing study
FG00013 subjects
FG00113 subjects
FG0027 subjects
FG00326 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: Venetoclax 400 mg + Azacitidine 20 mg/m^2
Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 24 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles.
Venetoclax: Tablet: Oral
Azacitidine: Subcutaneous (SC) or intravenous (IV) injection
BG001
Part 1: Venetoclax 400 mg + Azacitidine 36 mg/m^2
Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 24 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles.
Venetoclax: Tablet: Oral
Azacitidine: Subcutaneous (SC) or intravenous (IV) injection
BG002
Part 1: Venetoclax 400 mg + Azacitidine 50 mg/m^2
Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 24 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles.
Venetoclax: Tablet: Oral
Azacitidine: Subcutaneous (SC) or intravenous (IV) injection
Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles to determine recommended phase 3 dose (RPTD).
Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles at the RPTD.
Venetoclax: Tablet: Oral
Azacitidine: Oral Tablet
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00023
BG00123
BG00220
BG00330
BG00416
BG005112
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00053.1± 13.97
BG00157.3± 13.89
BG00255.6± 16.26
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00013
BG00111
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Dose-Limiting Toxicities (DLTs) of Venetoclax in Combination With Azacitidine (AZA) (Part 1)
DLTs are any of the hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax as described in the protocol and evaluated by the Investigator and the sponsor.
Data included are subject to a cutoff date of 05Oct2022.
Posted
Count of Participants
Participants
Up to 28 days (Cycle 1)
ID
Title
Description
OG000
Part 1: Venetoclax 400 mg + Azacitidine 20 mg/m^2
Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 24 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles.
Venetoclax: Tablet: Oral
Azacitidine: Subcutaneous (SC) or intravenous (IV) injection
OG001
Part 1: Venetoclax 400 mg + Azacitidine 36 mg/m^2
Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 24 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles.
Venetoclax: Tablet: Oral
Azacitidine: Subcutaneous (SC) or intravenous (IV) injection
OG002
Part 1: Venetoclax 400 mg + Azacitidine 50 mg/m^2
Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 24 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles.
Venetoclax: Tablet: Oral
Azacitidine: Subcutaneous (SC) or intravenous (IV) injection
Units
Counts
Participants
OG00022
OG00119
OG00216
Title
Denominators
Categories
Neutropenia
Title
Measurements
OG0003
OG0014
OG0024
Leukopenia
Primary
Number of Participants With DLTs of Venetoclax in Combination With Oral AZA (Part 3 Dose Finding Portion)
DLTs are hematologic toxicities consisting of any Grade ≥ 3 neutropenia or thrombocytopenia lasting more than 7 days and nonhematologic toxicities as described in the protocol and evaluated by the Investigator and the Sponsor. In addition, AEs that lead to omitting > 20% of the scheduled dose within the cycle is considered as a DLT unless clearly related to underlying disease. Treatment delay due to toxicity lasting greater than 14 days since the last dose of Venetoclax is also considered a DLT.
Data included are subject to a cutoff date of 05Oct2022.
Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles to determine recommended phase 3 dose (RPTD).
Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles at the RPTD.
Venetoclax: Tablet: Oral
Azacitidine: Oral Tablet
Time Frame
All-cause mortality and adverse event tables include events reported from the time of informed consent to the interim cutoff date of 05OCT2022. The median time on follow-up was 446, 687, 389 days for Part 1 VEN400_AZA20, VEN400_AZA36, VEN400_AZA50 and 67.5, 275 days for Part 3 Dose Level 1 (VEN400_CC200), Dose Level 2 (VEN400_CC300), respectively.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part 1: Venetoclax 400 mg + Azacitidine 20 mg/m^2
Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 24 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles.
Venetoclax: Tablet: Oral
Azacitidine: Subcutaneous (SC) or intravenous (IV) injection
3
23
5
23
21
23
EG001
Part 1: Venetoclax 400 mg + Azacitidine 36 mg/m^2
Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 24 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles.
Venetoclax: Tablet: Oral
Azacitidine: Subcutaneous (SC) or intravenous (IV) injection
5
23
7
23
22
23
EG002
Part 1: Venetoclax 400 mg + Azacitidine 50 mg/m^2
Participants will receive venetoclax once daily (QD) (Days 1-28) for up to 24 cycles, azacitidine (AZA) QD on Days 1-5 of each 28 day cycle for up to 6 cycles.
Venetoclax: Tablet: Oral
Azacitidine: Subcutaneous (SC) or intravenous (IV) injection
Participants will receive venetoclax QD for up to 24 cycles, AZA QD on Days 1 to 14 of each 28-day cycle for up to 24 cycles to determine recommended phase 3 dose (RPTD).